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Completed

NCT Number: NCT01440972

Assessment of Efficacy of Low Intensity Resistance Training in Women at Risk for Symptomatic Knee Osteoarthritis

The purpose of this study is to asses the efficacy of a 4 week low-intensity resistance training program with concurrent application of partial blood flow restriction (PBFR) to the exercising limbs to improve quadriceps strength and size, leg muscle power, and mobility in women at risk for developing symptomatic knee osteoarthritis. The primary outcome will be change in isotonic double leg-press 1 repetition maximum (1RM) strength. The investigators will test the following hypotheses. In comparison with low-intensity resistance training without use of PBFR, a four-week low-intensity resistance-training program with PBFR will:

Primary Hypothesis: Increase (a) double leg-press 1RM strength and (b) isokinetic knee extensor strength

Secondary Hypotheses:

1. Increase quadriceps muscle volume assessed by MRI 2. Increase lower limb muscle power on (a) double leg-press at 40% 1RM and (b) a timed stair climb 3. Not adversely effect knee pain or quality of life assessed by the Knee injury and Osteoarthritis Outcome Score (KOOS) questionnaire

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Key information

Conditions

Knee Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Osteoarthritis, Knee Rheumatic Diseases Symptomatic Knee Osteoarthritis

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

University of Iowa

Iowa City, Iowa, 52242, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Female
  • Age 45-65
  • BMI greater than or equal to 25 kg/m2, or a history of a knee joint injury or surgery, or knee symptoms (pain, aching, or stiffness) on most of the last 30 days, or knee osteoarthritis

Exclusion criteria

  • Resistance training at any time in the last 3 months prior to study
  • Bilateral knee replacement
  • Lower limb amputation
  • Lower limb surgery in the last 6 months that affects walking ability or ability to exercise
  • Back, hip or knee problems that affect walking ability or ability to exercise
  • Unable to walk without a cane or walker
  • Inflammatory joint or muscle disease such as rheumatoid or psoriatic arthritis or polymyalgia rheumatica
  • Multiple sclerosis
  • Known neuropathy
  • Self-report of Diabetes
  • Currently being treated for cancer or having untreated cancer
  • Terminal illness (cannot be cured or adequately treated and there is a reasonable expectation of death in the near future)
  • Peripheral Vascular Disease
  • History of myocardial infarction or stroke in the last year
  • History of deep venous thrombosis
  • Chest pain during exercise or at rest
  • Use of supplemental oxygen
  • Inability to follow protocol (e.g. lack of ability to attend visits or understand instructions)
  • Staff concern for subject health (such as history of dizziness/faintness or current restrictions on activity)
  • Concurrent study participation (such as the MOST study)
  • Unable to attend more than 2 days within any 1 week or unable to attend 4 or more sessions during the study

Treatment and study plan

partial blood flow restriction (PBFR)

Other

low intensity resistance training with partial blood flow restriction 3 times/week for 4 weeks.

low intensity resistance training

Other

low intensity resistance training without partial blood flow restriction

Primary outcomes

  1. Change in Isotonic Double Leg-press 1 Repetition Maximum Strength Scaled to Body Mass

    Time frame: 4 weeks

Secondary outcomes

  1. Change in Quadriceps Muscle Volume by Magnetic Resonance Imaging

    Time frame: 4 weeks

  2. Change in Lower Limb Muscle Power by Double Leg-press at 40% 1 Repetition Maximum

    Time frame: 4 weeks

  3. Change in Knee Injury and Osteoarthritis Outcome Score Pain Subscale

    Time frame: 4 weeks

    KOOS consists of 5 subscales; Pain, other Symptoms, Function in daily living (ADL), Function in sport and recreation (Sport/Rec) and knee related Quality of life QOL. The last week is taken into consideration when answering the questions. Standardized answer options are given (5 Likert boxes) and each question gets a score from 0 to 4. A normalized score (100 indicating no symptoms and 0 indicating extreme symptoms) is calculated for each subscale. KOOS is patient-administered, the format is user friendly, and takes about 10 minutes to fill out. Only the pain sub scale was used for the reported study.

  4. Change in Isokinetic Knee Extensor Strength

    Time frame: 4 weeks

Sponsors and collaborators

Lead sponsor

University of Iowa

Other

Collaborators

  • The American Geriatrics Society

Registry information

Acronym: PBFR2

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Sep 27, 2011
Registry last updated
Dec 5, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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